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Tag: biotechnology


Cell and Gene Therapy, Industry

BioMarin’s hemophilia gene therapy recommended for approval in Europe

June 24, 2022

Via: Biopharma Dive

The regulatory agency that recommends whether new drugs should be approved in Europe has thrown its support behind a gene therapy for the rare bleeding disorder hemophilia A, putting the potentially curative treatment one step closer to market. People with […]


Industry, Vaccines

COVID Vaccines Saved 20 Million Lives Worldwide in First Year

June 24, 2022

Via: Drugs.com

Nearly two-thirds of the world’s population has had at least one COVID-19 vaccine, which has prevented nearly 20 million deaths, new research finds. The study from Imperial College London was the first to quantify the impact of vaccines on a […]


Industry, Vaccines

Moderna says COVID booster works against Omicron subvariants

June 23, 2022

Via: Pharmaphorum

The news came hard on the heels of Moderna’s announcement that it will build a research and manufacturing facility in the UK to produce COVID and other mRNA jabs, and an additional order for 60 million doses that could be […]


FDA, Regulations

FDA suspends US testing of Sarepta Duchenne drug over safety concerns

June 23, 2022

Via: Biopharma Dive

Sarepta is known for several RNA-based medicines that it’s brought to market for Duchenne muscular dystrophy, each of which help patients produce a shortened form of the muscle-protecting protein they would otherwise lack. But the drugs only produce small amounts […]


News

Merck ups the stakes in pneumococcal jab face-off with Pfizer

June 22, 2022

Via: Pharmaphorum

One of these – dubbed V116 – is a cocktail of 21 Streptococcus pneumoniae serotypes designed to have the most benefit in adult populations, and it has just cleared a phase 1/2 trial as it embarks on a phase 3 […]


Industry, Pharma

US frets over pharma supply chain security

June 22, 2022

Via: Pharmaphorum

In a global economy, across a number of industries, low-margin products are often manufactured in countries where labour is cheap. The pharmaceutical industry is no different, with India and China becoming two of the leading manufacturers and exporters of generic […]


Cell and Gene Therapy, Industry

A biotech startup launches with $38M to develop a cystic fibrosis gene therapy

June 21, 2022

Via: Biopharma Dive

Vertex’s latest treatment for cystic fibrosis is a “triple combination” drug called Trikafta, which like others from Vertex boosts the activity of a protein that’s defective in people with the disease. It has quickly become a go-to treatment, entrenching Vertex’s […]


Industry, Vaccines

EMA Starts Rolling Review of Adapted COVID-19 Vaccines

June 21, 2022

Via: Biopharm International

The European Medicines Agency (EMA) has begun a rolling review of the Spikevax vaccine that has been adapted to protect against two variant strains of SARS-CoV-2, the agency announced on June 17, 2022. The review will focus on non-clinical laboratory […]


Industry, Vaccines

With CDC Approval, COVID Shots For Kids Under 5 Ready for Delivery

June 20, 2022

Via: Drugs.com

After a final sign-off on Saturday from the head of the U.S. Centers for Disease Control and Prevention, COVID-19 vaccines for children younger than 5 have finally become a reality. “This expands eligibility for vaccination to nearly 20 million additional […]


News

Pfizer takes stake in French Lyme disease jab partner Valneva

June 20, 2022

Via: Pharmaphorum

The deal gives Valneva a cash injection that it will be able to use to advance Lyme disease candidate VLA15 towards the market, but the revised licensing terms means that the French biotech will shoulder more of the financial cost […]


Clinical Trials, Research and Development

Pharmacy chain Walgreens plans to disrupt clinical trial sector

June 17, 2022

Via: Pharmaphorum

The company says it plans to use a “flexible” model, drawing on both decentralised trial (DCT) and conventional site-based models via its Health Corner and Village Medical outlets at various Walgreens locations across the US. The move follows in the […]


Industry, Vaccines

FDA advisors back COVID jabs for very young children

June 16, 2022

Via: Pharmaphorum

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to zero in favour of both vaccines in this age group, in light of rising rates of hospitalisations and deaths that have been seen in the very young during […]